Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

A randomised trial of diabetes intervention in the community to help achieve reduced glucose elevation: Diabetes IN-CHARGE

Acronym

Diabetes IN-CHARGE

Study hypothesis

This trial will determine if supplementing a community-based diabetes program with an automated system that generates specific evidence-based tailored recommendations to individuals/MDs based on responses to a self-administered questionnaire lowers hemoglobin A1c levels (A1c) more than the community-based program (i.e. Diabetes Hamilton) alone.

As of 15/01/2008, this record was updated to include an extended anticipated end date due to recruitment taking longer than anticipated; the initial end date at the time of registration was 31/07/2007 was updated to 30/06/2009.

As of 26/02/2009 this record was updated to include another extension to the anticipated end date to allow for completion of all follow-ups. The previous end date was 30/06/2009 and this has now been updated to 31/12/2009.

Ethics approval

McMaster University Research Ethics Board gave approval on the 31st August 2004.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 2 diabetes

Intervention

Participants in the community with type 2 diabetes will be enrolled in Diabetes Hamilton, fill out a questionnaire, and have regular information regarding diabetes management sent to them and their MD. Allocation will be to either receive or not receive automated recommendations and reminders based on the questionnaire response, interpretation of their HbA1c, a customised list of resources, and simple tools to track glucose control, HbA1c and related variables.

Overall trial start date

01/04/2005

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

500 participants with type two diabetes, both sex, 30 years and older1. Type 2 diabetes of 1 or more years duration2. Ontario Health Insurance Plan (OHIP) coverage3. Registered in, or willingness to register in Diabetes Hamilton4. English fluency5. Provide consent6. Have home access to either mail, email or the internet7. Have a baseline HbA1c level greater than 7%

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Current pregnancy2. Institutionalised3. Cohabiting first degree relative of a participant in the study4. Inability to read or understand English5. Inability or unwillingness to consent or comply with the protocol6. Residence outside the city of Hamilton